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Precision for Medicine seeks a Regulatory Manager to provide regulatory development advice and guidance for clinical trials, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.
Key responsibilities include:
- Provide regulatory guidance throughout the clinical development lifecycle
- Compile, coordinate, and review applications to regulatory authorities including CTA/IND submissions, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications
- Develop and review documents for submission to regulatory authorities and ethics committees to ensure compliance with regulatory standards
- Serve as representative of Global Regulatory Affairs at project team meetings with external and internal customers
- Work within project teams and lead projects for assigned regions or globally as needed
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
- Maintain project plans, project trackers, and regulatory intelligence tools; keep regulatory leadership updated
- Assist in development of Regulatory Affairs Specialists and operational staff
- Provide input into regulatory strategy and timeline development for new study opportunities
- Establish company standards to ensure highest quality of submitted information
- Maintain current knowledge of regulations and guidance documents, providing analysis to project teams
- Support and enhance the corporate Regulatory function
The role requires expertise in clinical trial regulations, submission processes, and cross-functional collaboration with internal and external stakeholders.
